The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cell-dyn 1800 System.
| Device ID | K030513 |
| 510k Number | K030513 |
| Device Name: | CELL-DYN 1800 SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara, CA 95054 |
| Contact | John Dean |
| Correspondent | John Dean ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara, CA 95054 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740071141 | K030513 | 000 |
| 00380740013493 | K030513 | 000 |